Director, Drug Product and Analytical Development

Rezera is a clinical stage biotechnology company developing differentiated oral medicines targeting NLRP3, a key upstream driver of chronic inflammation implicated in common cardiovascular and neurologic diseases. With a wholly-owned, internally discovered pipeline led by a phase 3 ready ruvonoflast in cardiovascular disease and phase 2 ready trabzanoflast in neurologic disease, Rezera is advancing a new generation of oral anti-inflammatory medicines designed to reach the tissues affected by disease to target inflammation at its source.

Rezera is headquartered in Boston, MA, with an R&D base in Cambridge, UK. Learn more at

Rezera is a clinical stage biotechnology company developing differentiated oral medicines targeting NLRP3, a key upstream driver of chronic inflammation implicated in common cardiovascular and neurologic diseases. With a wholly-owned, internally discovered pipeline led by a phase 3 ready ruvonoflast in cardiovascular disease and phase 2 ready trabzanoflast in neurologic disease, Rezera is advancing a new generation of oral anti-inflammatory medicines designed to reach the tissues affected by disease to target inflammation at its source.

Rezera is headquartered in Boston, MA, with an R&D base in Cambridge, UK. Learn more at

The Company

This is an opportunity to shape the late-stage and commercial CMC strategy for ruvonoflast at a pivotal point in its development. The role offers substantial visibility and influence across the organisation, with direct responsibility for converting a promising clinical programme into a robust, regulator-ready and commercially sustainable product.

Reporting To: Head of Technical Operations

Location: Remote (UK preferred) or USA

We are seeking a Director, Drug Product and Analytical Development to provide technical and operational leadership for late-stage drug product development, clinical supplies, manufacturing and analytical activities, with primary responsibility for supporting ruvonoflast through Phase 3, regulatory submission, launch preparation and commercial supply readiness.

The successful candidate will be an experienced, hands-on CMC leader with deep expertise in oral small-molecule drug products, analytical development, stability strategy and outsourced manufacturing. Working in a virtual or highly outsourced biotechnology environment, this individual will direct CDMOs, contract testing laboratories and specialist consultants; ensure that development and validation programmes are phase-appropriate and commercially robust; and deliver high-quality CMC documentation for global regulatory submissions.

• Own and execute the drug product and analytical CMC strategy for ruvonoflast and other small-molecule programmes from late clinical development through registration, launch and lifecycle management.
• Provide technical oversight of oral solid-dose formulation, manufacturing processes, packaging and product presentation, ensuring robust control strategies and reliable, scalable supply.
• Lead external drug product development, scale-up, process optimisation, technology transfer, registration and validation batch manufacture, process performance qualification and commercial readiness activities.
• Support clinical manufacturing, packaging, labelling and distribution including IRT build and validation
• Develop and oversee integrated stability strategies and programmes for drug product, including registration stability, supportive studies, in-use and packaging studies, data trending, shelf-life assignment and responses to emerging stability signals.
• Lead analytical development and lifecycle activities for drug product, including method development, qualification, validation and transfer;…